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Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis eventually causes the involved skin to harden, limiting mobility, and can also damage other organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is currently investigating a human monoclonal antibody (CAT-192) that neutralizes active TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety, tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early stage diffuse Systemic Sclerosis.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of diffuse systemic sclerosis

Duration of disease 18 months or less

Modified Rodnan Skin Score in a range as identified by the study protocol

Evidence of worsening disease activity

Ability to attend follow-up assessments for a minimum of 9 months

Agree to delay elective surgery during the trial and up to 9 months after final infusion

Agree to delay reproduction during the trial and up to 9 months after final infusion

Exclusion Criteria:

Women who are pregnant or lactating

Clinical evidence of other definable connective tissue or autoimmune disease

Severe kidney, heart, lung, or gastrointestinal disease

Treatment with protocol-specified immunosuppressants within 4 weeks of starting the clinical study

Treatment with systemic corticosteroids in a dose greater than 10 mg/day of prednisone or equivalent (inhaled steroids at standard doses are allowed)

Current treatment by photopheresis

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043706